27 applicants
This job has closed.
Olympus Corporation of the Americas · 5 days ago
Senior Market Quality Engineer
Westborough, MA
Full-time
Onsite
Senior Level
$83K/yr - $112K/yr
5+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesMedical Device
Insider Connection @Olympus Corporation of the Americas
Responsibilities
Responsible and accountable for CAPA ownership, execution, and support for all applicable global Market Quality CAPA’s. This includes creation, management, and execution of local/global Market Quality procedures, work instructions, practices, and compliance to CAPA procedures, working in a cross-functional team with other Market Quality management/departments.
Responsible to support as required cross functional teams (Market Quality, COE, COE MDR Team) that receive CAPA actions. The teams will collaborate to develop appropriate actions to eliminate the non-conformances.
Create, review, and approve release of changes to QMS documentation. Coordinate with other functions and sites to ensure timely and accurate completion and efficient change processing.
Ensures that the market quality processes are standardized throughout the business and ensures that they are implemented consistently and correctly.
Identifies areas of focus through data-driven trending and brings solutions to management.
Support and participate in NCR process.
Support and participate in internal and external Quality Audits (including notified bodies and health authorities) and ensure related corrective action activities are completed in a robust and timely manner. Act as Audit Finding coordinator.
Provides resident expertise in the application of Quality Sciences including, statistics, data analysis, problem-solving, and the creation of system solutions for Quality System issues
All Other Essential Duties as assigned by Management.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Bachelor of Science, medical, engineering, or scientific discipline
Minimum of 5 years' experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations (QSR ) compliance and quality assurance
Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses
Demonstrated experience in developing and leading a top performing Quality team is required
Competent understanding of medical device regulations both domestic and international with specific expertise in; Regulator Inspections, Complaints and Regulatory reporting, and Corrective and Preventive Actions (CAPA)
Competent with Microsoft Office 365 Suite, Apple iOS, Adobe, DocuSign, and Windows platforms
Up to 25% domestic travel, if not co-located with an Olympus manufacturing and/or service center
Benefits
Competitive salaries
Annual bonus
401(k) with company match
Comprehensive Medical, Dental, Visions coverage effective on start date
24/7 Employee Assistance Program
Free virtual live and on-demand wellness classes
Work-life balance supportive culture with hybrid and remote roles
12 Paid Holidays
Educational Assistance
Parental Leave and Adoption Assistance
Volunteering and charitable donation match programs
Diversity & Inclusion Programs including Colleague Affinity Networks
On-Site Child Daycare, Café, Fitness Center
Company
Olympus Corporation of the Americas
At Olympus, we put a lot of good back into the world, and what we do, really matters.
5,001-10,000 employees
H1B Sponsorship
Olympus Corporation of the Americas has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (4)
2022 (3)
2021 (3)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Abigail Hunter-Syed
Director
Lyne Charron-Keller
Executive Director, Global Marketing, Respiratory Business
Recent News
2023-10-25
Company data provided by crunchbase
